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Thalidomide for Multiple Myeloma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00038233
Collaborator
Celgene Corporation (Industry)
27
Enrollment
1
Location
1
Arm
71
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study attempts to examine the potential efficacy of thalidomide in the treatment of patients with previously untreated multiple myeloma. The trial focuses on patients with asymptomatic and indolent disease who do not require immediate chemotherapy. We intend to treat asymptomatic patients with an initial dose of 200 mg each evening, increasing to a maximum of 800 mg.

Thalidomide is supplied as 50 mg capsules to be taken by mouth. The initial dose will be 200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion) daily provided there are no side effects.

Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days.

Once a maximum tolerated dose has been reached free of side effects, that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance. Only patients who have received at least 200 mg/d for at least 2 months will be considered evaluable for response. For patients in remission, treatment will be continued at the maximum dose free of side effects until relapse. Selected patients <55 years of age who achieve remission may be eligible for stem cell transplant (SCT) in which case thalidomide will be discontinued prior to SCT.

Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Thalidomide for Multiple Myeloma
Study Start Date :
May 1, 1999
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
Apr 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thalidomide

200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)

Drug: Thalidomide
200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)
Other Names:
  • Thalomid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose of Thalidomide [14 day cycles]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify.

    • Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium >11.5 mg%), anemia (Hgb <8.5 gm/dl), renal failure (creatinine >2.0 mg/dl), high serum lactate dehydrogenase (>300 U/L) or plasma cell leukemia (>1000/ul) are ineligible.

    • Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required.

    • Patients must have Zubrod performance of 1 or less.

    • Patients must provide written informed consent indicating that they are aware of the investigational nature of this study.

    • Life expectancy should exceed 1 year.

    • Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas M. D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • Celgene Corporation

    Investigators

    • Principal Investigator: Donna M. Weber, MD, BS, UT MD Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00038233
    Other Study ID Numbers:
    • DM98-359
    First Posted:
    May 30, 2002
    Last Update Posted:
    Oct 31, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by M.D. Anderson Cancer Center
    myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide

    Study Results

    No Results Posted as of Oct 31, 2018